Trial Outcomes & Findings for Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder (NCT NCT00601367)

NCT ID: NCT00601367

Last Updated: 2014-06-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 480 participants
• Primary outcome timeframe: 28 weeks
• Results posted on: 2014-06-20

Participant Flow

Participant milestones

Measure	Flibanserin Flexible Dose Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.
Overall Study STARTED	480
Overall Study COMPLETED	293
Overall Study NOT COMPLETED	187

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

Baseline characteristics by cohort

Measure	Flibanserin Flexible Dose n=480 Participants Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site. flibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati
Age, Customized 18-29 years	97 participants n=5 Participants
Age, Customized 30-39 years	211 participants n=5 Participants
Age, Customized 40-49 years	170 participants n=5 Participants
Age, Customized 50 years and older	2 participants n=5 Participants
Sex: Female, Male Female	480 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	442 participants n=5 Participants
Race/Ethnicity, Customized White Hispanic	8 participants n=5 Participants
Race/Ethnicity, Customized Black	4 participants n=5 Participants
Race/Ethnicity, Customized Missing	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 weeks

Outcome measures

Measure	Flibanserin Flexible Dose n=480 Participants Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.
Frequency of Adverse Events patients with any adverse event	331 participants with any adverse event
Frequency of Adverse Events patients with drug-related adverse events	206 participants with any adverse event
Frequency of Adverse Events patients with adverse events leading to discontinu	58 participants with any adverse event
Frequency of Adverse Events patients with severe adverse events	51 participants with any adverse event
Frequency of Adverse Events patients with serious adverse events	9 participants with any adverse event

Adverse Events

Flibanserin Flexible Dose

Serious events: 9 serious events

Other events: 275 other events

Deaths: 0 deaths

Serious adverse events

Measure	Flibanserin Flexible Dose n=480 participants at risk Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.
Infections and infestations gastroenteritis	0.21% 1/480 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer in situ	0.21% 1/480 • Number of events 1
Nervous system disorders Migraine with aura	0.21% 1/480 • Number of events 1
Nervous system disorders Neuralgia	0.21% 1/480 • Number of events 1
Gastrointestinal disorders Abdominal pain	0.21% 1/480 • Number of events 1
Reproductive system and breast disorders Uterine polyp	0.42% 2/480 • Number of events 2
Reproductive system and breast disorders ovarian cyst	0.21% 1/480 • Number of events 1
Congenital, familial and genetic disorders Exomphalos	0.21% 1/480 • Number of events 1

Other adverse events

Measure	Flibanserin Flexible Dose n=480 participants at risk Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.
Nervous system disorders Fatigue	14.4% 69/480 • Number of events 78
Nervous system disorders Headache	10.6% 51/480 • Number of events 71
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	9.8% 47/480 • Number of events 54
Gastrointestinal disorders Nausea	8.5% 41/480 • Number of events 47
Nervous system disorders Dizziness	8.3% 40/480 • Number of events 52
Nervous system disorders Somnolence	5.6% 27/480 • Number of events 29

Additional Information

Krista Barbour, Ph.D.

Sprout Pharmaceuticals

Phone: 9198820850

Email: kbarbour@sproutpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place